2 дня назад
IT System and Validation Analyst (GxP)
128 750 - 163 083$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
IT System and Validation Analyst (GxP): Ensuring the validation, compliance, and lifecycle control of GxP-regulated computerized systems with an accent on risk-based CSV strategies, data integrity, and regulatory requirements. Focus on designing validation deliverables, coordinating implementations and upgrades, and supporting audits, inspections, and remediation activities.
Location: Watertown, MA or Northbridge, MA, United States
Salary: $128,750–$163,083 USD per year
Company
is an ophthalmology company developing and commercializing therapeutics for serious retinal diseases and the prevention of blindness.
What you will do
- Provide QA oversight for the validation and compliance of GxP-regulated computerized systems throughout their lifecycle.
- Collaborate with system owners and cross-functional stakeholders to apply GAMP 5, 21 CFR Part 11, EU Annex 11, and FDA CSA guidance.
- Lead validation activities for system implementations, upgrades, integrations, cloud/SaaS solutions, migrations, and decommissioning.
- Author, review, and approve validation plans, requirements, risk assessments, traceability matrices, test protocols, reports, and data integrity assessments.
- Maintain systems in a state of control through change management, periodic reviews, requalification, deviation management, and CAPA activities.
- Coordinate with vendors and project teams, support audits and inspections, and mentor colleagues on CSV and documentation standards.
Requirements
- 5–7 years of direct Computer System Validation experience in an FDA-regulated or GxP environment.
- Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.
- Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, risk-based validation, data integrity, access controls, security, and audit trails.
- Experience validating systems in laboratory, manufacturing, quality, and/or cloud-based environments.
- Experience managing change controls, deviations, CAPAs, periodic reviews, audits, inspections, or supplier assessments.
- Strong technical writing, analytical, problem-solving, communication, and collaboration skills.
Culture & Benefits
- Work in a regulated ophthalmology environment focused on improving outcomes for patients with serious retinal diseases.
- Culture emphasizes transformational innovation, integrity, compassionate excellence, and inclusive collaboration.
- Commitment to diversity, inclusion, and equal employment opportunity.
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